Feasibility Study of a Novel Diet-Based Intervention for Prostate Cancer.

摘要

My goal is to develop a practical, diet-based intervention for prostate cancer. During the award period, I implemented a randomized clinical trial of a novel dietary intervention for prostate cancer that promotes vegetable intake among prostate cancer patients on active surveillance. I successfully expanded the protocol described in the original Statement of Work from a randomized clinical trial involving 2 study sites and 200 patients to a national trial involving at least 45 study sites and 464 patients. As of September 24, 2013, the study had achieved 60% of its targeted accrual and was enrolling an average of 10 patients per month. To perform the expanded trial, I helped secure almost $3 million in additional funding. I presented a study abstract at a national meeting, wrote a manuscript that is pending submission to a peer-reviewed journal, and completed the first planned interim analysis (the results of which exceeded expectations). This award has greatly increased my national exposure, led directly to leadership positions in a NCI-sponsored clinical research network, and honed my clinical research skills. This study is the first national, Phase III trial designed to test a diet-based intervention for prostate cancer and the first nonindustry sponsored trial designed to test an intervention of any kind in prostate cancer patients on active surveillance. When completed, it has the potential to substantially inform treatment paradigms for prostate cancer.